Setting specifications for related impurities in antibiotics - Scientific guideline

HumanVeterinaryScientific guidelines

This guideline applies to human and veterinary medicines.

This document provides guidance for marketing authorisation applications on setting specifications for related impurities in antibiotics. It applies to antibacterial substances that are fermentation products or semisynthetic substances derived from fermentation products.

Keywords: Antibiotics, specifications, related impurities

Current effective version

Adopted guideline on setting specifications for related impurities in antibiotics

Reference Number: EMA/CHMP/CVMP/QWP/199250/2009 corr

English (EN) (417.26 KB - PDF)

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Document history - First version (current)

Adopted guideline on setting specifications for related impurities in antibiotics

Reference Number: EMA/CHMP/CVMP/QWP/199250/2009 corr

English (EN) (417.26 KB - PDF)

First published: Last updated:
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Overview of comments received on setting specifications for related impurities in antibiotics

Reference Number: EMA/CHMP/CVMP/QWP/310350/2012

English (EN) (615.22 KB - PDF)

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Draft guideline on setting specifications for related impurities in antibiotics

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/CVMP/QWP/199250/2009

English (EN) (205.08 KB - PDF)

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Concept paper on the development of a guideline on setting specifications for related impurities in antibiotics

Reference Number: CHMP/CVMP/QWP/136351/08

English (EN) (50.3 KB - PDF)

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